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Non-invasive Brain Stimulation

rTMS for Cognitive Impairment in Parkinson's Disease (TMSCogReP Trial)

Phase 1 & 2
Recruiting
Led By Sandra L. Kletzel, PhD BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
50 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 12 weeks
Awards & highlights

TMSCogReP Trial Summary

This trial will test whether a non-invasive brain stimulation treatment can improve thinking for people with Parkinson's disease who have mild cognitive impairments.

Who is the study for?
This trial is for Veterans over 50 with Parkinson's disease who have mild cognitive impairment, can speak and read English, and are treated at Hines VA Hospital or Jesse Brown VA Medical Center. Participants must be on stable medication that won't change during the study. Those with severe depression, dementia, certain implants, history of seizures or metal in their body cannot join.Check my eligibility
What is being tested?
The trial tests if repetitive transcranial magnetic stimulation (rTMS) using a MagVenture MagProX100 stimulator can improve thinking abilities in those with Parkinson's experiencing mild cognitive issues. It assesses the safety and effects of rTMS on behavior and brain function.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or twitching facial muscles during treatment. There's also a small risk of seizure but this is rare.

TMSCogReP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

TMSCogReP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score

TMSCogReP Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: active rTMSExperimental Treatment1 Intervention
For active rTMS, a butterfly coil and MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) will be used. One rTMS session will consist of 40 trains of 5sec each at 110% of resting motor threshold and 15Hz will be provided at the left DLPFC.
Group II: sham rTMSPlacebo Group1 Intervention
For sham rTMS, the procedure will be carried out at the left DLPFC but a sham coil will be used. The MagVenture coil has an active side and a placebo side allowing a double-blind study to be conducted. The sham system looks, sounds and feels like active rTMS.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,228 Total Patients Enrolled
Sandra L. Kletzel, PhD BAPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03836950 — Phase 1 & 2
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT03836950 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively looking for participants in this trial?

"Yes, the information on clinicaltrials.gov points out that this clinical trial is presently searching for candidates. The clinical trial was first posted on 4/1/2020 and was last updated on 10/19/2022. The study is enrolling 56 participants at 2 locations"

Answered by AI

How many individuals are taking part in this trial?

"That is correct, the online information does show that this study is searching for patients to enroll. This specific trial was first posted on April 1st 2020 and was last edited on October 19th 2020. The research team hopes to recruit 56 individuals from 2 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Edward Hines Jr. VA Hospital, Hines, IL
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I would like to have more info on clinical trials for Parkinson's.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Homw Many visits to the hospital do I need to make ?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
rTMS to Improve Cognition in Parkinson's
2020. "rTMS to Improve Cognition in Parkinson's". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836950.
All > Mci > Mild Cognitive Impairment
~2 spots leftby Jun 2024
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